Alerts and enforcement
Sterility and Contamination Alert Center
Microbial contamination; testing failures; recalls; facility actions; patient impact; current status.
USP General Chapter 797 sets standards for compounding STERILE preparations — injections, infusions, ophthalmics. Chapter 797 is the sterile counterpart to Chapter 795. It governs air quality classification, engineering controls such as ISO-classified cleanrooms, personnel garbing and competency, environmental monitoring, and sterility assurance.
Key findings
- Chapter 797 is the sterile counterpart to Chapter 795. It governs air quality classification, engineering controls such as ISO-classified cleanrooms, personnel garbing and competency, enviro
- It assigns beyond-use dates by risk category and by whether sterility testing was performed. Those dates are typically short — days to weeks — which is why a long-dated compounded sterile pr
- The 2012 New England Compounding Center outbreak, which killed dozens through contaminated steroid injections, is the event that drove both the DQSA and the strengthening of sterile compound
- Compliance is assessed by state boards for 503A pharmacies. For 503B outsourcing facilities, FDA assesses against CGMP, which subsumes and exceeds Chapter 797.
- Entity-specific compliance with this standard is not asserted on this page.
| Microbial contamination | Verification Pending |
|---|---|
| Testing failures | Verification Pending |
| Recalls | Verification Pending |
| Facility actions | Verification Pending |
| Patient impact | Verification Pending |
| Current status. | Verification Pending |
| Federal framework | License Verified FDA sources verified 2026-07-23 |
| Entity-specific data | Verification Pending |
What this standard actually requires
USP General Chapter 797 sets standards for compounding STERILE preparations — injections, infusions, ophthalmics.
Chapter 797 is the sterile counterpart to Chapter 795. It governs air quality classification, engineering controls such as ISO-classified cleanrooms, personnel garbing and competency, environmental monitoring, and sterility assurance.
It assigns beyond-use dates by risk category and by whether sterility testing was performed. Those dates are typically short — days to weeks — which is why a long-dated compounded sterile preparation warrants a question.
The 2012 New England Compounding Center outbreak, which killed dozens through contaminated steroid injections, is the event that drove both the DQSA and the strengthening of sterile compounding oversight.
Compliance is assessed by state boards for 503A pharmacies. For 503B outsourcing facilities, FDA assesses against CGMP, which subsumes and exceeds Chapter 797.
What is established about microbial contamination?
For compounded drug sterility alerts, microbial contamination is one of the elements this monitor tracks. The record that holds it is named in the source map below, and the verification state is shown in the snapshot above rather than asserted in prose.
Where microbial contamination has not been checked against that source at this snapshot, the field renders Verification Pending. That is a statement about this platform's verification state and carries no implication about any entity.
What is established about testing failures?
For compounded drug sterility alerts, testing failures is one of the elements this monitor tracks. The record that holds it is named in the source map below, and the verification state is shown in the snapshot above rather than asserted in prose.
Where testing failures has not been checked against that source at this snapshot, the field renders Verification Pending. That is a statement about this platform's verification state and carries no implication about any entity.
What is established about recalls?
For compounded drug sterility alerts, recalls is one of the elements this monitor tracks. The record that holds it is named in the source map below, and the verification state is shown in the snapshot above rather than asserted in prose.
Where recalls has not been checked against that source at this snapshot, the field renders Verification Pending. That is a statement about this platform's verification state and carries no implication about any entity.
What is established about facility actions?
For compounded drug sterility alerts, facility actions is one of the elements this monitor tracks. The record that holds it is named in the source map below, and the verification state is shown in the snapshot above rather than asserted in prose.
Where facility actions has not been checked against that source at this snapshot, the field renders Verification Pending. That is a statement about this platform's verification state and carries no implication about any entity.
What is established about patient impact?
For compounded drug sterility alerts, patient impact is one of the elements this monitor tracks. The record that holds it is named in the source map below, and the verification state is shown in the snapshot above rather than asserted in prose.
Where patient impact has not been checked against that source at this snapshot, the field renders Verification Pending. That is a statement about this platform's verification state and carries no implication about any entity.
What does this page establish?
It establishes the framework and the source map for compounded drug sterility alerts, drawn from FDA primary sources verified on 2026-07-23. Framework facts — what the statute says, what registration means, which agency holds which record — are stable and checkable, and they are cited inline.
What it does not establish is any entity-specific fact. This platform separates those two categories deliberately, because they carry different verification burdens. A statutory definition can be cited once and relied on; a pharmacy's licence status changes continuously and must be checked at the moment of use.
What this means
- The framework governing compounded drug sterility alerts is cited to FDA primary sources.
- The record holding each element of microbial contamination is named.
- Verification dates are published on every field so staleness is visible.
What this does not mean
- That any entity connected with compounded drug sterility alerts is compliant or non-compliant.
- That the absence of a record indicates the absence of an issue.
- That this platform certifies or endorses any facility or preparation.
Status terms on this page follow the platform's published status vocabulary.
- No entity-specific record relating to compounded drug sterility alerts has been verified at this snapshot.
- Microbial contamination may change without notice to this platform.
- Regulatory positions change through rulemaking, guidance, and enforcement action.
- Records held by different agencies may disagree; conflicts are published as conflicts.
Sources verified for this page — 10 sources
- FDA — Information for Outsourcing Facilitieschecked 2026-07-23
- FDA — Q&A: Outsourcing Facility Registrationchecked 2026-07-23
- FDA — Registered Outsourcing Facilitieschecked 2026-07-23
- FDA — Aligning Federal and State Regulation of Compounderschecked 2026-07-23
- FDA — Outsourcing Facility Feeschecked 2026-07-23
- FDA — Compounded Drug Products That Are Essentially Copieschecked 2026-07-23
- FDA — Proposes to Exclude Semaglutide, Tirzepatide and Liraglutide from 503B Bulks List (30 Apr 2026)checked 2026-07-23
- FDA — Registration of Human Drug Compounding Outsourcing Facilities (guidance)checked 2026-07-23
- Nevada Board of Pharmacy — Notice of FDA Declaratory Orders (tirzepatide, semaglutide)checked 2026-07-23
- FDA — Outsourcing Facility Fees guidancechecked 2026-07-23
Why compounded drug sterility alerts is hard to verify
Three structural features of compounding oversight make verification harder than it looks, and they apply to this topic as much as any other.
First, authority is split. Federal and state regulators hold different records about the same entity, and neither register is complete on its own. Second, registration and inspection are separate events — a facility can be registered for years without an inspection, so a registration date tells you nothing about oversight intensity. Third, a record's currency is invisible without its date: a licence verified last year and a licence verified today look identical in a citation.
That is why every field on this platform carries a check date, and why a field without one renders as pending rather than as a fact.
| Structural feature | Consequence for verification | How this platform handles it |
|---|---|---|
| Split federal and state authority | No single register is complete for any entity | Both systems are named per field, and neither is presented as sufficient |
| Registration precedes inspection | A registration is not evidence of oversight | Registration and inspection are reported as separate facts |
| Records go stale silently | A citation without a date implies currency it may not have | Every field carries its own verification date |
| Observations are not findings | A Form 483 is frequently reported as a violation | Observations and final actions are stored and displayed separately |
| Resolved actions persist online | Closed matters get reported as current | Current and historical status are distinct states, never merged |
Related records in this section
Section hub: Alerts and enforcement · Methodology · Status definitions · Right to respond
Frequently asked questions
What does this page cover on compounded drug sterility alerts?
Microbial contamination; testing failures; recalls; facility actions; patient impact; current status.
What is established about microbial contamination?
Microbial contamination is tracked as part of compounded drug sterility alerts. The record holding it is named in the source map on this page, and its verification state is shown in the status snapshot rather than asserted in prose.
What is established about testing failures?
testing failures is tracked as part of compounded drug sterility alerts. The record holding it is named in the source map on this page, and its verification state is shown in the status snapshot rather than asserted in prose.
What is established about recalls?
recalls is tracked as part of compounded drug sterility alerts. The record holding it is named in the source map on this page, and its verification state is shown in the status snapshot rather than asserted in prose.
What would trigger an alert on compounded drug sterility alerts?
Only a current official action from a named agency, with its scope stated. Consumer allegations, media reports and review sentiment never generate an alert here.
Sources
- FDA — Information for Outsourcing Facilities
- FDA — Q&A: Outsourcing Facility Registration
- FDA — Registered Outsourcing Facilities
- FDA — Aligning Federal and State Regulation of Compounders
- FDA — Outsourcing Facility Fees
- FDA — Compounded Drug Products That Are Essentially Copies
- FDA — Proposes to Exclude Semaglutide, Tirzepatide and Liraglutide from 503B Bulks List (30 Apr 2026)
- FDA — Registration of Human Drug Compounding Outsourcing Facilities (guidance)
- Nevada Board of Pharmacy — Notice of FDA Declaratory Orders (tirzepatide, semaglutide)
- FDA — Outsourcing Facility Fees guidance
Update history
| Date | Change |
|---|---|
| 2026-07-23 | Record published at current snapshot. |
Dates change only for substantive updates. Entities may submit a correction or response through the right-to-respond process.